Heart FailureHABIT-IINCT02351063
HF Assessment With BNP in the Home: Part II
A study testing Changes of heart failure medications in people with Heart Failure, run by Alere San Diego at 13 sites in 6 countries.
Trial summary
HABIT-II is a feasibility study aimed at home monitoring of patients with heart failure. B-type natriuretic peptide (BNP) has strong correlations to the severity of heart failure. Lower BNP levels are closely associated with better clinical outcomes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- Changes of heart failure medications
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 13 sitesin 6 countries
- Study dates
- Apr 2014to Jul 2014
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults at least 18 years of age
- Willing to sign an Informed Consent Form
- Ambulatory subjects with worsening HF defined as:
- Admitted to the hospital or treated in an outpatient clinic with a diagnosis of decompensated HF for which treatment will be administered; or
- Seen in an outpatient setting (i.e. heart failure clinic, general practice or cardiology office, urgent care unit) with a documented history of HF and with signs of worsening HF condition or decompensation, where worsening HF condition is defined as one or more of the following;
- Increase in NYHA class with worsening symptoms (i.e. dyspnea, fatigue) at same level of activity
Show all 15Show fewer
- Symptoms requiring change in dosage of one or more HF medication.
- - Physical evaluation consistent with worsening HF signs (i.e. elevated jugular vein pressure (JVP), ankle edema, dyspnea, abdominal distension, >4 lb. or >1.8 kg weight increase in past week)
- Must have some documented evidence of their current LVEF status as < 40% or > 40% (preferably a determination of %LVEF) at the time they begin BNP self-testing or within 2 months of enrollment
- At least one BNP value during the index hospitalization or within 2 weeks of the index visit to clinic with worsening HF that meet the following criteria
- 400 pg/mL BNP (3200 pg/mL NT-proBNP) for subjects diagnosed with HFREF (LVSD < 40%) adjusted for BMI > 35
- 300 pg/mL BNP (2400 pg/mL NT-proBNP) for subjects diagnosed with HFPEF (LVSD > 40%) adjusted for BMI > 35
- Deemed willing and suitable for HeartCheck BNP home testing and participation in this study;
- AND
- Successfully trained and deemed proficient on how to perform a fingerstick and to use the HeartCheck system.
Who cannot join
- Primary diagnosis at presentation of the index event of Acute Coronary Syndrome (ACS) (myocardial infarction (MI) or unstable angina).
- Prior heart transplant or planned transplant within the next 3 months
- Current or planned use of left ventricular assist device (LVAD) within 3 months
- Current or planned inotrope dependent therapy within 3 months
- Current or planned percutaneous coronary intervention (PCI) or coronary artery bypass graft (CABG) within 3 months
- Life expectancy less than 6 months for causes other than for cardiovascular reasons
Show all 12Show fewer
- End stage renal disease (estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73 m2)
- Other misc. cardiovascular and non-cardiovascular conditions such as amyloidosis, infiltrative cardiomyopathy, peripartum cardiomyopathy unless present for at least 12 months, acute myocarditis
- Receiving investigational medications or therapy
- Hematocrit known to be outside the 25-50% range of the HeartCheck system requirements
- Deemed likely to be noncompliant with protocol by the Investigator
- Residence in regions where transmission of test data or home visits are not possible
Trial locations and contacts
13 sites in 6 countries.
13 sites in 6 countries
United States6 sites
Massachusetts General Hospital
Boston, Massachusetts, 02114
Medical University of South Carolina
Charleston, South Carolina, 29425
Ohio State University Medical Center
Columbus, Ohio, 43210
Veterans Administration Medical Center
Loma Linda, California, 92357
Veterans Administration Medical Center
Minneapolis, Minnesota, 55417
Veterans Administration Medical Center
San Diego, California, 92161
New Zealand2 sites
University of Auckland
Auckland
Christchurch Hospital
Christchurch
About this study
HABIT-II is a feasibility study aimed at home monitoring of patients with heart failure. B-type natriuretic peptide (BNP) has strong correlations to the severity of heart failure. Lower BNP levels are closely associated with better clinical outcomes. The goal of HABIT-II is to demonstrate that the results of daily patient self-testing of BNP at home will provide sufficient information to guide physicians to modify therapy and lower BNP levels over time.
Read the detailed description
This is a single arm multi-center pilot study. Subjects with heart failure (HF) who are discharged following an acute decompensated heart failure (ADHF) event and subjects who are seen as outpatients with worsening signs or symptoms of HF, who meet enrollment criteria, are candidates for this study. Subjects with HF with reduced left ventricular ejection fraction (HFREF) and subjects with HF with preserved ejection fraction (HFPEF) are eligible. The eventual objective of this area of research is to demonstrate that HF subjects assisted by frequent B-type natriuretic peptide (BNP) measurements integrated into a home health management system have improved clinical outcomes. The specific objective of this study is to demonstrate that frequent BNP measurements integrated into a home health management system used by physicians to modify or intensify therapy will lead to a reduced risk of ADHF events as measured by a reduction in BNP levels. Subjects will be asked to test their BNP at home every day for a period of 180 days using the AlereTM HeartCheck System (the Test System). In addition to BNP, weights and signs and symptoms of HF will be collected each day of testing. The HeartCheck data is transmitted via a secure wireless protocol to the HealthCOM health monitoring portal where it is available to the medical staff.
Enrollment goal is 110 evaluable subjects. Potential subjects who meet the study's inclusion and exclusion criteria will be interviewed about their interest in participating in the study. Potential subjects that show interest in the study will be judged for their willingness, ability and reliability to perform fingerstick BNP measurements every day for 180 days while at home and be able to report the results using the HeartCheck system. All qualifying subjects who agree to participate and provide Informed Consent will be trained to use the HeartCheck system which includes daily BNP measurements, daily body weight measurements, and daily health survey questions. Subjects who successfully complete their training will be judged on their proficiency in all study activities. If found to be proficient; they will use the system at home. After a short lead-in period, an algorithm (similar in concept to a moving average) will be applied to the BNP data resulting in a BNP-based parameter and alerts will be created when this parameter is rising, or during periods of sustained high BNP. The patient's physician and medical staff will be required to evaluate all BNP based alert notifications and determine if a change in HF treatment is advisable. All changes in HF treatment, with or without BNP-based alerts, are at the discretion of the treating physician and medical staff of the institution.
The primary endpoint of the study is a significant lowering of BNP across the population. At approximately 1, 3 and 6 months after enrollment, subjects will return to the clinic for physical examination, clinical assessment, and review of interval medical status by their health care provider. In addition, if warranted, a home health care professional may visit the subject at home at any time during the study when additional counseling or training may be of benefit for compliance to the protocol.
- Conditions
- Heart Failure
- Being tested
- Changes of heart failure medications
- Keywords
- Heart failure, BNP, home testing, remote monitoring
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Changes of heart failure medicationsDrug
Also called Diuretics, Beta blockers, ACE inhibitors, Angiotensin II receptor antagonists
Changes in dosage of existing medications or introduction of new medications to improve heart failure condition.
| Study group | Role | What they receive |
|---|---|---|
| Daily BNP | Experimental | Subjects will be asked to test their BNP at home every day for a period of 180 days using the AlereTM HeartCheck System (the Test System). In addition to BNP, weights and signs and symptoms of HF will be collected each day of testing. The HeartCheck data is transmitted via a secure wireless protocol to the HealthCOM health monitoring portal where it is available to the medical staff. The subject's's physician and medical staff will be required to evaluate the data and determine if a change in HF treatment is advisable. All changes of heart failure medications are at the discretion of the treating physician and medical staff of the institution. Receives: Drug: Changes of heart failure medications |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in BNP
After a short lead-in period, an algorithm (similar in concept to a moving average) will be applied to the BNP data resulting in a BNP-based parameter. The primary endpoint of the study is a significant lowering of BNP across the population, such that values for the population are reduced to levels below a predetermined threshold and kept below the threshold for the duration of subsequent testing and observation.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2015 (estimated)
- Study startApr 2014
- Primary completionJul 2014
- Study completionJul 2014
Why it stopped: Sponsor's discretion to terminate study prematurely for further evaluation.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alere San Diego
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Alan Maisel, MD, Principal investigator, San Diego Veterans Administration Medical CenterKen McDonald, MD, Principal investigator, St Vincent's University Hospital, Ireland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02351063
- Sponsor's protocol ID
- BSTE-0144
- Acronym
- HABIT-II
- Status last verified
- Dec 2023
- First submitted
- 12 Jan 2015
- Last updated
- 3 Jan 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Maisel A, Barnard D, Jaski B, Frivold G, Marais J, Azer M, Miyamoto MI, Lombardo D, Kelsay D, Borden K, Iqbal N, Taub PR, Kupfer K, Clopton P, Greenberg B. Primary results of the HABIT Trial (heart failure assessment with BNP in the home). J Am Coll Cardiol. 2013 Apr 23;61(16):1726-35. doi: 10.1016/j.jacc.2013.01.052. Epub 2013 Mar 26.
PubMed 23500322Januzzi JL Jr, Rehman SU, Mohammed AA, Bhardwaj A, Barajas L, Barajas J, Kim HN, Baggish AL, Weiner RB, Chen-Tournoux A, Marshall JE, Moore SA, Carlson WD, Lewis GD, Shin J, Sullivan D, Parks K, Wang TJ, Gregory SA, Uthamalingam S, Semigran MJ. Use of amino-terminal pro-B-type natriuretic peptide to guide outpatient therapy of patients with chronic left ventricular systolic dysfunction. J Am Coll Cardiol. 2011 Oct 25;58(18):1881-9. doi: 10.1016/j.jacc.2011.03.072.
PubMed 22018299Motiwala SR, Januzzi JL Jr. Using biomarkers to "guide" heart failure management: current perspectives and future directions. Cardiol Rev. 2013 May-Jun;21(3):127-34. doi: 10.1097/CRD.0b013e3182769073.
PubMed 23032578Maisel A, Mueller C, Adams K Jr, Anker SD, Aspromonte N, Cleland JG, Cohen-Solal A, Dahlstrom U, DeMaria A, Di Somma S, Filippatos GS, Fonarow GC, Jourdain P, Komajda M, Liu PP, McDonagh T, McDonald K, Mebazaa A, Nieminen MS, Peacock WF, Tubaro M, Valle R, Vanderhyden M, Yancy CW, Zannad F, Braunwald E. State of the art: using natriuretic peptide levels in clinical practice. Eur J Heart Fail. 2008 Sep;10(9):824-39. doi: 10.1016/j.ejheart.2008.07.014. Epub 2008 Aug 29.
PubMed 18760965Troughton RW, Frampton CM, Yandle TG, Espiner EA, Nicholls MG, Richards AM. Treatment of heart failure guided by plasma aminoterminal brain natriuretic peptide (N-BNP) concentrations. Lancet. 2000 Apr 1;355(9210):1126-30. doi: 10.1016/s0140-6736(00)02060-2.
PubMed 10791374
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HF Assessment With BNP in the Home: Part II
- ClinicalTrials.gov ID
- NCT02351063
- Acronym / sponsor ID
- HABIT-II / BSTE-0144
- Conditions
- Heart Failure
- Keywords
- Heart failure, BNP, home testing, remote monitoring
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor's discretion to terminate study prematurely for further evaluation.
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Alere San DiegoIndustry (pharma, biotech, devices)
- Study start
- Apr 2014
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 30 Jan 2015 (estimated)
- Results
- Posted 4 Feb 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
HABIT-II is a feasibility study aimed at home monitoring of patients with heart failure. B-type natriuretic peptide (BNP) has strong correlations to the severity of heart failure. Lower BNP levels are closely associated with better clinical outcomes. The goal of HABIT-II is to demonstrate that the results of daily patient self-testing of BNP at home will provide sufficient information to guide physicians to modify therapy and lower BNP levels over time.
Detailed description
This is a single arm multi-center pilot study. Subjects with heart failure (HF) who are discharged following an acute decompensated heart failure (ADHF) event and subjects who are seen as outpatients with worsening signs or symptoms of HF, who meet enrollment criteria, are candidates for this study. Subjects with HF with reduced left ventricular ejection fraction (HFREF) and subjects with HF with preserved ejection fraction (HFPEF) are eligible. The eventual objective of this area of research is to demonstrate that HF subjects assisted by frequent B-type natriuretic peptide (BNP) measurements integrated into a home health management system have improved clinical outcomes. The specific objective of this study is to demonstrate that frequent BNP measurements integrated into a home health management system used by physicians to modify or intensify therapy will lead to a reduced risk of ADHF events as measured by a reduction in BNP levels. Subjects will be asked to test their BNP at home every day for a period of 180 days using the AlereTM HeartCheck System (the Test System). In addition to BNP, weights and signs and symptoms of HF will be collected each day of testing. The HeartCheck data is transmitted via a secure wireless protocol to the HealthCOM health monitoring portal where it is available to the medical staff.
Enrollment goal is 110 evaluable subjects. Potential subjects who meet the study's inclusion and exclusion criteria will be interviewed about their interest in participating in the study. Potential subjects that show interest in the study will be judged for their willingness, ability and reliability to perform fingerstick BNP measurements every day for 180 days while at home and be able to report the results using the HeartCheck system. All qualifying subjects who agree to participate and provide Informed Consent will be trained to use the HeartCheck system which includes daily BNP measurements, daily body weight measurements, and daily health survey questions. Subjects who successfully complete their training will be judged on their proficiency in all study activities. If found to be proficient; they will use the system at home. After a short lead-in period, an algorithm (similar in concept to a moving average) will be applied to the BNP data resulting in a BNP-based parameter and alerts will be created when this parameter is rising, or during periods of sustained high BNP. The patient's physician and medical staff will be required to evaluate all BNP based alert notifications and determine if a change in HF treatment is advisable. All changes in HF treatment, with or without BNP-based alerts, are at the discretion of the treating physician and medical staff of the institution.
The primary endpoint of the study is a significant lowering of BNP across the population. At approximately 1, 3 and 6 months after enrollment, subjects will return to the clinic for physical examination, clinical assessment, and review of interval medical status by their health care provider. In addition, if warranted, a home health care professional may visit the subject at home at any time during the study when additional counseling or training may be of benefit for compliance to the protocol.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Daily BNP | Experimental | Drug: Changes of heart failure medicationsSubjects will be asked to test their BNP at home every day for a period of 180 days using the AlereTM HeartCheck System (the Test System). In addition to BNP, weights and signs and symptoms of HF will be collected each day of testing. The HeartCheck data is transmitted via a secure wireless protocol to the HealthCOM health monitoring portal where it is available to the medical staff. The subject's's physician and medical staff will be required to evaluate the data and determine if a change in HF treatment is advisable. All changes of heart failure medications are at the discretion of the treating physician and medical staff of the institution. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Adults at least 18 years of age
- Willing to sign an Informed Consent Form
- Ambulatory subjects with worsening HF defined as:
- Must have some documented evidence of their current LVEF status as < 40% or > 40% (preferably a determination of %LVEF) at the time they begin BNP self-testing or within 2 months of enrollment
- At least one BNP value during the index hospitalization or within 2 weeks of the index visit to clinic with worsening HF that meet the following criteria
Key exclusion criteria (12 listed)
- Primary diagnosis at presentation of the index event of Acute Coronary Syndrome (ACS) (myocardial infarction (MI) or unstable angina).
- Prior heart transplant or planned transplant within the next 3 months
- Current or planned use of left ventricular assist device (LVAD) within 3 months
- Current or planned inotrope dependent therapy within 3 months
- Current or planned percutaneous coronary intervention (PCI) or coronary artery bypass graft (CABG) within 3 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Changes of heart failure medicationsAlso: Diuretics, Beta blockers, ACE inhibitors, Angiotensin II receptor antagonistsChanges in dosage of existing medications or introduction of new medications to improve heart failure condition. | Drug | Daily BNP |
Primary outcome
Change in BNP
Time frame: 6 months
After a short lead-in period, an algorithm (similar in concept to a moving average) will be applied to the BNP data resulting in a BNP-based parameter. The primary endpoint of the study is a significant lowering of BNP across the population, such that values for the population are reduced to levels below a predetermined threshold and kept below the threshold for the duration of subsequent testing and observation.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 23500322Maisel A, Barnard D, Jaski B, Frivold G, Marais J, Azer M, Miyamoto MI, Lombardo D, Kelsay D, Borden K, Iqbal N, Taub PR, Kupfer K, Clopton P, Greenberg B. Primary results of the HABIT Trial (heart failure assessment with BNP in the home). J Am Coll Cardiol. 2013 Apr 23;61(16):1726-35. doi: 10.1016/j.jacc.2013.01.052. Epub 2013 Mar 26.
- Background: PubMed 22018299Januzzi JL Jr, Rehman SU, Mohammed AA, Bhardwaj A, Barajas L, Barajas J, Kim HN, Baggish AL, Weiner RB, Chen-Tournoux A, Marshall JE, Moore SA, Carlson WD, Lewis GD, Shin J, Sullivan D, Parks K, Wang TJ, Gregory SA, Uthamalingam S, Semigran MJ. Use of amino-terminal pro-B-type natriuretic peptide to guide outpatient therapy of patients with chronic left ventricular systolic dysfunction. J Am Coll Cardiol. 2011 Oct 25;58(18):1881-9. doi: 10.1016/j.jacc.2011.03.072.
- Background: PubMed 23032578Motiwala SR, Januzzi JL Jr. Using biomarkers to "guide" heart failure management: current perspectives and future directions. Cardiol Rev. 2013 May-Jun;21(3):127-34. doi: 10.1097/CRD.0b013e3182769073.
- Background: PubMed 18760965Maisel A, Mueller C, Adams K Jr, Anker SD, Aspromonte N, Cleland JG, Cohen-Solal A, Dahlstrom U, DeMaria A, Di Somma S, Filippatos GS, Fonarow GC, Jourdain P, Komajda M, Liu PP, McDonagh T, McDonald K, Mebazaa A, Nieminen MS, Peacock WF, Tubaro M, Valle R, Vanderhyden M, Yancy CW, Zannad F, Braunwald E. State of the art: using natriuretic peptide levels in clinical practice. Eur J Heart Fail. 2008 Sep;10(9):824-39. doi: 10.1016/j.ejheart.2008.07.014. Epub 2008 Aug 29.
- Background: PubMed 10791374Troughton RW, Frampton CM, Yandle TG, Espiner EA, Nicholls MG, Richards AM. Treatment of heart failure guided by plasma aminoterminal brain natriuretic peptide (N-BNP) concentrations. Lancet. 2000 Apr 1;355(9210):1126-30. doi: 10.1016/s0140-6736(00)02060-2.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alan Maisel, MD principal investigator
San Diego Veterans Administration Medical Center
Ken McDonald, MD principal investigator
St Vincent's University Hospital, Ireland
13 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Changes of heart failure medications in people with Heart Failure, run by Alere San Diego at 13 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 3 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in United States, New Zealand, United Kingdom, Ireland, Netherlands and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 Feb 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in BNP (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02351063, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jan 2024.